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Influenza A Virus, H5N1 SubtypePhase 2NCT03497845

Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59

A Phase 2 study testing VN, IN and dk/BANG in people with Influenza A Virus, H5N1 Subtype, run by Biomedical Advanced Research and Development Authority at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza A Virus, H5N1 Subtype
What is being tested?
VN, IN and dk/BANG
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
6 sitesUnited States
Study dates
15 Mar 2018to 19 Nov 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Is a male or nonpregnant female 18 to 49 years of age, inclusive, on Day 1 (first vaccination).
  • Will avoid nonstudy vaccinations until 21 days after the last vaccination.
  • Provides written informed consent prior to the initiation of any study-related procedures.
  • Has a stable health status, as established by physical examination, vital sign measurements, and medical history.
  • Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
  • Is able to understand and comply with planned study procedures.
  • Lives a reasonable distance from the site to be able to travel to and from the site for follow-up visits and agrees to go to the site for evaluation in the case of an adverse event.
  • Agrees to stay in contact with the site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.

Who cannot join

  • Has a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal, or chicken protein), or allergy to squalene-based adjuvants or has had severe reactions following previous immunizations with contemporary influenza virus vaccines.
  • A woman who has a positive urine pregnancy test prior to vaccination in this study or a woman who is breastfeeding.
  • A female of childbearing potential (a) who refuses to use an acceptable method of birth control (b) from Day 1 (first vaccination) to end-of-study visit and, if sexually active, who has not used a reliable birth control method for at least 2 months prior to Day 1 (first vaccination).
  • Female of childbearing potential is defined as post-onset menarche and premenopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >1 year, tubal ligation >1 year, bilateral salpingo-oophorectomy, or hysterectomy.
  • Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female Day 1 (first vaccination), and this male is the sole partner for that subject (The information on the male sterility can come from the site personnel's review of the subject's medical records or interview with the subject on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
  • Is immunosuppressed as a result of an underlying illness or treatment, or anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months prior to Day 1 (first vaccination).
Show all 25Show fewer
  • Has an active neoplastic disease or a history of any hematologic malignancy. A subject with superficial skin cancer who does not require intervention other than local excision is not excluded.
  • Has long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening. (Low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
  • Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
  • Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
  • Has a neurological or psychiatric diagnosis, which, although stable, is judged by the investigator to render the potential subject unable or unlikely to comply with the protocol or to provide accurate safety reports.
  • Has received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to Day 1 (first vaccination).
  • Has received any live vaccine within 4 weeks or inactivated vaccines within 2 weeks prior to Day 1 (first vaccination). This includes seasonal influenza vaccines.
  • Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes potentially immune-mediated medical conditions such as Guillain-Barré syndrome, narcolepsy, current or history of autoimmune or chronic inflammatory disease.
  • Has a first-degree relative with narcolepsy.
  • Has an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per subject report, within 3 days prior to each vaccination. Subjects with an acute illness can be rescheduled for a vaccination as long as the vaccination visit is within the visit window. Note that subjects may return for randomization following resolution of the acute illness as long as recruitment remains open and subjects are within 14 days of signing consent.
  • Has a Grade 2 or greater (by US Food and Drug Administration toxicity grade) safety laboratory value at screening.
  • Has received an experimental agent (vaccine, biologic, device, blood product, or medication) within 1 month prior to Day 1 (first vaccination) in this study or plans receipt of an experimental agent during the study period.
  • Is participating or plans to participate in another interventional clinical study (either active or follow-up phase) during the study period.
  • Has received an influenza H5 vaccine in the past or has a history of H5 influenza infection prior to enrollment.
  • Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • Has a history of alcohol or drug abuse within 5 years prior to Day 1 (first vaccination).
  • Has a body mass index >35 kg/m2.
  • Has any condition that would, in the opinion of the investigator, place him or her at an unacceptable risk of injury or render him or her unable to meet the requirements of the protocol (including site of injection reactogenicity assessments).
  • Is a first-degree relative of any person working on this study: site or sponsor.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

  • Central Kentucky Research Associates Inc

    Lexington, Kentucky, 40509

  • Optimal Research

    Peoria, Illinois, 61614

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • Optimal Research

    Rockville, Maryland, 20850

  • Optimal Research

    San Diego, California, 92108

Other trials in United States

About this study

Official title: Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Vaccination Strategies With Stockpiled Inactivated Monovalent Influenza A(H5) Vaccines Administered Intramuscularly With Either AS03 or MF59® as Adjuvant

The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains.

The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.

Being tested
VN, IN, dk/BANG, gf/WA, bhg/QL
Keywords
vaccine, adjuvant, Influenza in Birds, MF59, AS03
Medical subject headings
Influenza in Birds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VNBiological

    Also called A/Vietnam/1203/2004 vaccine antigen strain H5N1

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

  • INBiological

    Also called A/Indonesia/05/2005 vaccine antigen strain H5N1

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

  • dk/BANGBiological

    Also called A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

  • gf/WABiological

    Also called A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

  • bhg/QLBiological

    Also called A/barheaded goose/Qinghai Lake/1A/2005 vaccine antigen strain H5N1

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

  • AS03 adjuvantBiological

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

  • MF59 adjuvantBiological

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Study groups in NCT03497845
Study groupRoleWhat they receive
a VN with AS03 Adjuvant, then gf/WA with AS03 AdjuvantExperimentalSingle dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
Receives: Biological: VN; Biological: gf/WA; Biological: AS03 adjuvant
b IN with AS03 Adjuvant, then gf/WA with AS03 AdjuvantExperimentalSingle dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
Receives: Biological: IN; Biological: gf/WA; Biological: AS03 adjuvant
c dk/BANG with AS03 Adjuvant, then gf/WA with AS03 AdjuvantExperimentalSingle dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
Receives: Biological: dk/BANG; Biological: gf/WA; Biological: AS03 adjuvant
d gf/WA with AS03 Adjuvant, then IN with AS03 AdjuvantExperimentalSingle dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
Receives: Biological: IN; Biological: gf/WA; Biological: AS03 adjuvant
e dk/BANG with AS03 Adjuvant, then bhg/QL with AS03 AdjuvantExperimentalTwo doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
Receives: Biological: dk/BANG; Biological: bhg/QL; Biological: AS03 adjuvant
f gf/WA with AS03 Adjuvant, then bhg/QL with AS03 AdjuvantExperimentalTwo doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
Receives: Biological: gf/WA; Biological: bhg/QL; Biological: AS03 adjuvant
g VN with MF59 Adjuvant, then gf/WA with MF59 AdjuvantExperimentalSingle dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Receives: Biological: VN; Biological: gf/WA; Biological: MF59 adjuvant
h IN with MF59 Adjuvant, then gf/WA with MF59 AdjuvantExperimentalSingle dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Receives: Biological: IN; Biological: gf/WA; Biological: MF59 adjuvant
i dk/BANG with MF59 Adjuvant, then gf/WA with MF59 AdjuvantExperimentalSingle dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Receives: Biological: dk/BANG; Biological: gf/WA; Biological: MF59 adjuvant
j gf/WA with MF59 Adjuvant, then IN with MF59 AdjuvantExperimentalSingle dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Receives: Biological: IN; Biological: gf/WA; Biological: MF59 adjuvant
k dk/BANG with MF59 Adjuvant, then bhg/QL with MF59 AdjuvantExperimentalTwo doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22); followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
Receives: Biological: dk/BANG; Biological: bhg/QL; Biological: MF59 adjuvant
l gf/WA with MF59 Adjuvant, then bhg/QL with MF59 AdjuvantExperimentalTwo doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
Receives: Biological: gf/WA; Biological: bhg/QL; Biological: MF59 adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

    Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms.

    Subjects in A-D and G-J did not receive 3 doses

    Measured: 8 days post-vaccination

  2. Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

    Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses

    Measured: 8 days post-vaccination

  3. Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series

    Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

    Measured: Day 43

  4. Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series

    Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

    Measured: Day 163

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2018
  2. Study start15 Mar 2018
  3. Primary completion19 Nov 2019
  4. Study completion19 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03497845
Sponsor's protocol ID
BP-I-16-005
Status last verified
Jun 2020
First submitted
13 Mar 2018
Last updated
14 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VN, IN and dk/BANG in people with Influenza A Virus, H5N1 Subtype, run by Biomedical Advanced Research and Development Authority at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series (time frame: 8 days post-vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03497845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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